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Transcranial Magnetic Stimulation for Methamphetamine Use Disorder During Pregnancy

StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to learn whether transcranial magnetic stimulation, also called TMS, is a practical and acceptable treatment option for methamphetamine use disorder during pregnancy. The study will enroll pregnant women who have methamphetamine use disorder. The main questions it aims to answer are: 1. Can pregnant women with methamphetamine use disorder be successfully enrolled and complete TMS treatment? 2. Is TMS acceptable to pregnant participants, their caregivers or partners, and clinicians involved in their care? 3. Is it feasible to collect maternal and infant health information during pregnancy and after delivery? Researchers will compare standard 4-week TMS, accelerated 2-week TMS, and treatment as usual to see which approach is more practical and better tolerated during pregnancy. Participants will: * Be randomly assigned to receive standard TMS, accelerated TMS, or treatment as usual. * Complete study visits during pregnancy and follow-up visits after treatment. * Complete questionnaires about substance use, cravings, mood, anxiety, sleep, quality of life, and side effects. * Provide urine drug tests and have vital signs and safety assessments completed. * Allow the study team to review pregnancy and infant medical records. * Some participants will complete interviews about their experiences and views of TMS during pregnancy.
Trial Details
NCT Number NCT07849530
Lead Sponsor University of Utah
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Methamphetamine Use Disorder, Pregnancy
Enrollment 45 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov